Product Details

Vascepa

Icosapent Ethyl
1 g
Capsule


DIN/PIN/NPN

02495244

Manufacturer

HLS Therapeutics Inc.

Formulary Listing Date

2022-07-21  

Unit Price

2.4500

Amount MOH Pays

2.4500

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

C10AX

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Cardiology Drugs

Icosapent Ethyl

  • Brand(s): Vascepa
  • Dosage Form/Strength: 1 g capsules
  • Effective date: July 21, 2022

Initiation criteria:

For the secondary prevention of cardiovascular events in patients with established cardiovascular disease who meet all of the following criteria: 

  1. Aged 45 years of age or older; AND 

  2. Has been diagnosed with established cardiovascular disease [e.g., coronary heart disease (e.g., myocardial infarction, angina, coronary procedure, abdominal aortic aneurysm), cerebrovascular disease (e.g., stroke, transient ischemic attack, carotid obstruction), or peripheral artery disease]; AND 

  3. Has documented fasting triglyceride level greater than or equal to 1.7 mmol/L (150 mg/dL) and lower than 5.6 mmol/L (500 mg/dL) at baseline1; AND 

  4. Has documented low-density lipoprotein cholesterol level greater than 1.0 mmol/L (40 mg/dL) and lower than 2.6 mmol/L (100 mg/dL) at baseline1 and is receiving maximally tolerated statin dose for a minimum of 4 weeks.2
    [Note: Statin dose should be targeted to achieve a low-density lipoprotein cholesterol lower than 2.0 mmol/L (80 mg/dL)]. 

1Baseline levels should be measured within the preceding 3 months prior to starting treatment with icosapent ethyl.

2Case-by-case consideration may be provided for patients who have been on a stable statin regimen consisting of a maximally tolerated moderate to high-intensity statin dose AND who have a baseline low-density lipoprotein cholesterol level of greater or equal to 2.6 mmol/L (100mg/dL)1 AND/OR who have a documented contraindication/intolerance to statins. Details of the contraindication/intolerance must be provided. 

Renewal criteria:

Renewals will be considered in patients who continue to benefit from treatment and who do not develop unacceptable toxicities to treatment. 

Approved dose: up to 2 grams orally twice daily 

Initial approval duration: 2 years 

Renewal approval duration: 5 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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